[A multicenter randomized controlled study of temozolomide in 97 patients with malignant brain glioma].

Objective: To investigate the efficacy and safety of temozolomide (TMZ) and lomustine (CCNU) in malignant brain gliomas.

Methods: In this multicenter, randomized, double-blind, positive-controlled study, patients with malignant glioma of a histological grade III/IV were randomly divided into two groups. In experiment group, TMZ capsule 150 mg/m2 was given orally on days 1 through 5 and CCNU placebo 130 mg/m2 while on day 1. In control group, CCNU capsule 130 mg/m2 was taken orally on day 1 and TMZ placebo 150 mg/m2 while on days 1 through 5. In both groups drugs were given on the first 5 days of 28 day therapeutic course. Every patient was administered at least 3 cycles continuously.

Results: 97 patients were enrolled in the clinical trial, 86 cases of which were evaluable for efficacy. The basic conditions of patients in both groups were comparable. After 12 weeks, the response rates in TMZ and CCNU group were 35.71% and 9.09% (P < 0.01) respectively, and the clinical benefit rates in TMZ and CCNU group were 90.48% and 75.00% (P < 0.05) respectively. No obvious improvement was showed in quality of life and neural symptoms in both groups. The common side effects of TMZ were nausea and vomiting with grade I/II.

Conclusion: TMZ capsule can produce higher efficacy than CCNU in the treatment for refractory malignant brain glioma patients with an acceptable safety profile , indicating that TMZ could be an ideal chemotherapy selection for malignant brain glioma.